Monday, May 14, 2012

The U.S. Food and Drug Administration is alerting health care professionals and patients
about injuries and death associated with the use of an experimental
procedure sometimes called “liberation therapy” or the “liberation
procedure” to treat chronic cerebrospinal venous insufficiency (CCSVI).

Some
researchers believe that CCSVI, which is characterized by a narrowing
(stenosis) of veins in the neck and chest, may cause multiple sclerosis
(MS) or may contribute to the progression of the disease by impairing
blood drainage from the brain and upper spinal cord. However, studies
exploring a link between MS and CCSVI are inconclusive, and the criteria
used to diagnose CCSVI have not been adequately established.

“Because
there is no reliable evidence from controlled clinical trials that this
procedure is effective in treating MS, FDA encourages
rigorously-conducted, properly-targeted research to evaluate the
relationship between CCSVI and MS,” said William Maisel, M.D., M.P.H.,
chief scientist and deputy director for science in the FDA’s Center for
Devices and Radiological Health. “Patients are encouraged to discuss the
potential risks and benefits of this procedure with a neurologist or
other physician who is familiar with MS and CCSVI, including the CCSVI
procedures and their outcomes.”

The experimental
procedure uses balloon angioplasty devices or stents to widen narrowed
veins in the chest and neck. However, the FDA has learned of death,
stroke, detachment and migration of the stents, damage to the treated
vein, blood clots, cranial nerve damage and abdominal bleeding
associated with the experimental procedure. Balloon angioplasty devices
and stents have not been approved by the FDA for use in treating CCSVI.

MS
is a progressive, immune-mediated disorder of the brain and spinal
cord. In MS, the lining around nerve fibers, and often the nerve fibers
themselves, in the brain and spinal cord are injured, resulting in
significant and disabling neurological symptoms. The underlying cause of
MS is not known.

Complications following CCSVI treatment can be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

The
FDA also is notifying physicians and clinical investigators who are
planning or conducting clinical trials using medical devices to treat
CCSVI that they must comply with FDA regulations for investigational devices.
Any procedures conducted are considered significant risk clinical
studies and require FDA approval, called an investigational device
exemption.

In February 2012, the FDA sent a warning letter
to a sponsor/investigator who was conducting a clinical study of CCSVI
treatment without the necessary approval. The sponsor/investigator
voluntarily closed the study.

The FDA will
continue to monitor reports of adverse events associated with
“liberation therapy” or the “liberation procedure” and keep the public
informed as new safety information becomes available.

The
FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and
security of human and veterinary drugs, vaccines and other biological
products for human use, and medical devices. The agency also is
responsible for the safety and security of our nation’s food supply,
cosmetics, dietary supplements, products that give off electronic
radiation, and for regulating tobacco products.